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US20240033088A1 - Method for Producing a Covering Device for a Bone Defect; Covering Device for a Bone Defect; Method for at Least Partially Covering a Bone Defect by Means of a Bone Defect Covering Device Brought for this Purpose to an Insertion Position - Google Patents

Method for Producing a Covering Device for a Bone Defect; Covering Device for a Bone Defect; Method for at Least Partially Covering a Bone Defect by Means of a Bone Defect Covering Device Brought for this Purpose to an Insertion Position Download PDF

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Publication number
US20240033088A1
US20240033088A1 US17/618,549 US202017618549A US2024033088A1 US 20240033088 A1 US20240033088 A1 US 20240033088A1 US 202017618549 A US202017618549 A US 202017618549A US 2024033088 A1 US2024033088 A1 US 2024033088A1
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US
United States
Prior art keywords
top piece
bone
bone defect
defect site
fixing means
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Abandoned
Application number
US17/618,549
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English (en)
Inventor
Marcus Seiler
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
ReOss GmbH
Original Assignee
ReOss GmbH
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by ReOss GmbH filed Critical ReOss GmbH
Assigned to REOSS GMBH reassignment REOSS GMBH ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: SEILER, MARCUS
Publication of US20240033088A1 publication Critical patent/US20240033088A1/en
Abandoned legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61C—DENTISTRY; APPARATUS OR METHODS FOR ORAL OR DENTAL HYGIENE
    • A61C8/00—Means to be fixed to the jaw-bone for consolidating natural teeth or for fixing dental prostheses thereon; Dental implants; Implanting tools
    • A61C8/0003—Not used, see subgroups
    • A61C8/0004—Consolidating natural teeth
    • A61C8/0006—Periodontal tissue or bone regeneration
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/28—Bones
    • A61F2/2846—Support means for bone substitute or for bone graft implants, e.g. membranes or plates for covering bone defects
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/3094—Designing or manufacturing processes
    • A61F2/30942—Designing or manufacturing processes for designing or making customized prostheses, e.g. using templates, CT or NMR scans, finite-element analysis or CAD-CAM techniques
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/28—Bones
    • A61F2/2846—Support means for bone substitute or for bone graft implants, e.g. membranes or plates for covering bone defects
    • A61F2002/285—Fixation appliances for attaching bone substitute support means to underlying bone
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30003—Material related properties of the prosthesis or of a coating on the prosthesis
    • A61F2002/3006—Properties of materials and coating materials
    • A61F2002/30062—(bio)absorbable, biodegradable, bioerodable, (bio)resorbable, resorptive
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30316—The prosthesis having different structural features at different locations within the same prosthesis; Connections between prosthetic parts; Special structural features of bone or joint prostheses not otherwise provided for
    • A61F2002/30535—Special structural features of bone or joint prostheses not otherwise provided for
    • A61F2002/30561—Special structural features of bone or joint prostheses not otherwise provided for breakable or frangible
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/3094—Designing or manufacturing processes
    • A61F2/30942—Designing or manufacturing processes for designing or making customized prostheses, e.g. using templates, CT or NMR scans, finite-element analysis or CAD-CAM techniques
    • A61F2002/30952—Designing or manufacturing processes for designing or making customized prostheses, e.g. using templates, CT or NMR scans, finite-element analysis or CAD-CAM techniques using CAD-CAM techniques or NC-techniques
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/3094—Designing or manufacturing processes
    • A61F2002/30985—Designing or manufacturing processes using three dimensional printing [3DP]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2310/00—Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
    • A61F2310/00005—The prosthesis being constructed from a particular material
    • A61F2310/00011—Metals or alloys
    • A61F2310/00023—Titanium or titanium-based alloys, e.g. Ti-Ni alloys
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2310/00—Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
    • A61F2310/00389—The prosthesis being coated or covered with a particular material
    • A61F2310/00976—Coating or prosthesis-covering structure made of proteins or of polypeptides, e.g. of bone morphogenic proteins BMP or of transforming growth factors TGF

Definitions

  • the invention proceeds from a method for producing a covering device for a bone defect site, according to the type of claim 1 , a covering device for a bone defect site according to the type of claim 15 , and a method for at least partially covering a bone defect site by means of a bone defect site covering device brought for this purpose into an insertion position, according to the type of claim 28 .
  • Bone defect sites in the form of recesses or cavities in endogenous bone tissue are often filled with bone reconstruction material in bone surgery, for example in the reconstruction of bone in orthopaedic, neurosurgical or plastic surgery or in maxillofacial operations.
  • the bone reconstruction material generally consists of a mixture of synthetic bone substitute material (e.g. hydroxyl apatite granulate) and endogenous bone particles. So that the bone reconstruction material is substantially grown through with bone exclusively from the bone side, the recess, as described in patent document DE 43 02 708 C2, is closed by a covering membrane.
  • the covering membrane is fastened by fastening nails on the endogenous healthy bone, adjoining the bone defect site, which healthy bone is damaged by the fastening nails, wherein, as the covering membrane consists of a flexible material, the fastening requires a highest level of manual skill by the surgeon.
  • a covering membrane is described in patent document US 48 16 339 which consists of several layers, wherein these layers do not consist of resorbable membrane material. It is necessary here, if applicable, that after the healing of the bone defect, a second intervention is necessary in order to remove material which is foreign to the body.
  • an implant bed which is distinguished by a high fitting accuracy and stability, so that the attending doctor can easily handle it and implant it.
  • the implant bed made from hydroxl apatite, which has, on the side facing the mucous membrane, a thin membrane consisting in particular resorbable material for protection of the mucous membrane from mechanical effects and for protection of the implant bed from ingrowing tissue from the mucous membrane, is produced by a building-up production method so that the material property has a “gradient structure” in the sense of an in particular inwardly decreasing density.
  • a construction is provided having an in particular porous structure, and on the outer side of the implant bed, on which a structure is situated for mounting a dental implant and/or a denture, a compact construction is provided.
  • a covering device which has a top piece which has a side facing away from the bone defect and a side facing the bone defect and, if applicable, at least one fixing means for fixing the top piece on a bone, wherein the top piece consists of a dimensionally stable material which is at least partially in contact with the bone, and a side of the top piece facing the bone defect or a side of the top piece facing away from the bone defect corresponds to the shape of the regenerated bone, wherein the top piece has at least one positioning means.
  • the positioning of the top piece is indeed facilitated by the positioning means in an insertion position, however the problem is not thereby solved that the fixing of the top piece by means of a fixing means possibly requires a highest level of manual skill by the surgeon.
  • the method according to the invention for producing a covering device for a bone defect site designates a site of a bone (diseased, deformed, injured, altered through ageing processes, altered through degeneration (e.g. after dental extraction, tumour etc.) and/or altered in volume) (e.g.
  • the covering device for a bone defect site having the features of claim 15
  • the method according to the invention for the at least partial covering of a bone defect site by means of a bone defect covering site brought for this purpose into an insertion position, having the features of claim 29 have by comparison the advantage that the covering device consists of a top piece (e.g.
  • mould shell, rigid shell, shaped body which can be configured having one or several layers, and at least one fixing means for fixing the top piece on a bone, wherein on the top piece at least one fixing means suitable for the fixing of the top piece is detachably arranged by means of a connection, whereby an insertion of the covering device is greatly facilitated.
  • the method according to the invention for producing a covering device for a bone defect site which has a top piece and at least one fixing means for the top piece, consists of the following method steps:
  • CAD computer-aided design
  • CAM computer-aided manufacture
  • a fixing means position adapted specifically to the use of this fixing means, which fixing position enables a fixing of the top piece within the bone defect site or on the healthy bone, is predetermined in order to obtain through the manufacturing method a top piece on which at least one fixing means is detachably connected to the top piece in its fixing means position by means of at least one connection.
  • a guide is arranged for a tool, by which the creating of a bore, suitable for the fixing means, is enabled within the bone defect site or on the healthy bone.
  • the side of the top piece, formed in the manufacturing method, facing the bone defect or the side facing away from the bone defect corresponds at least partially to the shape of the regenerated bone, which through its regeneration if possible has the shape of a healthy bone again, in the target state.
  • the second dataset arises through calculation or was recorded at a time at which the bone was still a healthy bone at the bone defect site which is now to be regenerated.
  • the second dataset arises through calculation or was recorded at a time at which the bone was still a healthy bone at the bone defect site which is now to be regenerated.
  • the ideal state (target state) of the bone is documented so that it is known how a bone which is possibly to be regenerated later is to appear.
  • the recording of the dataset of the healthy bone should preferably take place at the age of 18 to 25 years.
  • the recording of the dataset of the healthy bone or respectively the recordings of the healthy bones take place after the healthy bone is fully grown.
  • the dataset of the healthy bone or respectively the datasets of the healthy bones are stored (preserved) on a storage medium for later use thereof.
  • the recording of the first data set represents the affected bone defect site in its three-dimensionality and/or the recording of the second dataset represents the shape of the still healthy bone in its three-dimensionality.
  • the recording of the first dataset, which represents the actual state, and/or the recording of the second dataset, which represents the target state takes place by at least one imaging method.
  • the recording of the first dataset and/or the recording of the second dataset takes place by at least one method which enables a three-dimensional presentation of a bone.
  • the recording of the first dataset and/or the recording of the second dataset take place by means of tomography, computer tomography, digital volume tomography, sonography or suchlike.
  • the top piece is formed by 3D printing and/or by means of milling.
  • At least one fastening device for at least one implant which is to be set and/or at least one predetermined breaking point and/or at least one positioning means are arranged on the top piece.
  • the fastening device can be configured for example as a recess.
  • At least one fastening device e.g. recess
  • the point in time of the exposing of the fastening device can lie here before or after the arranging of the covering device on the bone defect site.
  • At least one positioning means arranged on the top piece during the manufacture of the top piece, serves for the positioning of the top piece in an insertion position.
  • the positioning means is preferably arranged at the edge of the top piece.
  • at least one positioning means serves for the positioning of the top piece on a healthy bone adjoining the bone defect site, so that this at least one positioning means has a side facing away from the healthy bone and a side facing the healthy bone and at least partially corresponding thereto.
  • At least one predetermined breaking point is arranged between the top piece and a positioning means, whereby preferably a positioning means which rests on the healthy bone and is thus possibly bulky in an intrusive manner, e.g. after fixing of the top piece or after the regeneration of the bone at the bone defect site, can be removed from the possibly remaining top piece, and/or at least one predetermined breaking point is arranged between the top piece and at least one fixing means arranged on the top piece.
  • a cleaning- and/or sterilisation process is carried out during the manufacture of the top piece.
  • the top piece and/or at least one fixing means and/or at least one positioning means are formed from a dimensionally stable, in particular rigid, material.
  • a covering device By the method according to the invention for producing a covering device for a bone defect site, a covering device can be created, the top piece and/or fixing means of which for example of a synthetic material and/or of a material of autogenic, synergenic, allogenic or xenogenic origin, human and/or animal bones or respectively the human, animal or synthetic matrix has a shape by which the region situated between the bone and the desired shape of the regenerated bone is filled entirely or almost entirely.
  • a bone block is removed from the donor, said bone block being subsequently modelled if applicable by means of CAD/CAM.
  • the covering device for a bone defect site which has a top piece by which the bone defect site is able to be at least partially covered, wherein the top piece has a side facing away from the bone defect site and a side facing the bone defect site, or by which the bone defect side is able to be at least partially covered, and in addition a healthy bone adjoining the bone defect site is able to be at least partially covered, wherein the top piece has a side facing away from the healthy bone and a side facing away from the bone defect site and a side facing the healthy bone and a side facing the bone defect site, and a fixing means for fixing the top piece within the bone defect site and/or with at least one fixing means for fixing the top piece on the healthy bone adjoining the bone defect site, on the top piece at least one fixing means, suitable for fixing the top piece within the bone defect site or on the healthy bone adjoining the bone defect site, is arranged detachably by means of at least one connection arranged between the fixing means and the top piece, wherein the detaching of at least one connection
  • a fixing means position adapted specifically for the use of this fixing means is present on the top piece for a fixing means, which fixing means position enables a fixing of the top piece within the bone defect site or on the healthy bone, or on the top piece for at least one fixing means at least one fixing means position, adapted specifically to the use of at least one fixing means, is present, which enables a fixing of the top piece within the bone defect site or on the healthy bone, wherein at least one fixing means is detachably connected to the top piece by means of at least one connection in its fixing means position which is adapted specifically to the use of this fixing means.
  • the top piece has at least one predetermined breaking point.
  • the predetermined breaking point has the advantage that, in so far as the top piece is to be removed after a successful bone regeneration, this removal can take place in a minimally invasive manner, without “having to expose everything”, because the top piece, owing to the predetermined breaking point, can be broken up into at least two parts. The removal of the top piece (e.g. after a bone regeneration) is therefore very easily possible. Furthermore, the predetermined breaking point can serve for parts of the top piece, which are not or are no longer required, to be separated from the remainder of the top piece.
  • At least one fixing means which is preferably detachably connected to the top piece in its fixing means position adapted specifically to the use of this fixing means, projects over the side facing away from the bone defect site or the side of the top piece facing away from the healthy bone and/or the side facing the bone defect site or the side of the top piece facing the healthy bone.
  • the top piece has a guide for a tool at at least one fixing means position which is adapted to a fixing means.
  • a guide for a tool at at least one fixing means position which is adapted to a fixing means.
  • the creation of a bore, suitable for the fixing means, within the bone defect site or on the healthy bone is made possible.
  • the top piece consists of a dimensionally stable, in particular rigid, material.
  • the side facing the bone defect or the side of the top piece facing away from the bone defect corresponds at least partially to the shape of a regenerated bone at the bone defect site, which through its regeneration has the shape of a healthy bone again.
  • the material of the top piece is of organic and/or inorganic origin and/or the material of a fixing means is of organic and/or inorganic origin.
  • This can also be an autogenic, syngenic, allogenic, xenogenic, synthetic or alloplastic material.
  • the top piece and/or at least one fixing means consist at least partially of a biocompatible material.
  • the top piece and/or at least one fixing means and/or at least one positioning means can consist at least partially of a resorbable material.
  • the resorption time of the rigid shell can be controlled by its resorption gradient and/or the resorption time can also be less than six months, so that the implant can be inserted in a timely manner.
  • resorbable metals or alloys in particular magnesium or magnesium alloys, can be used.
  • the 3D models (e.g. the top piece and/or the fixing means) are preferably built up by the laser melting method under vacuum, wherein preferably a 3D printer is used.
  • the top piece and/or at least one fixing means and/or at least one positioning means consist at least partially of a biodegradable material.
  • the top piece and/or at least one fixing means and/or at least one positioning means consist at least partially of a polymer or a polymeric compound.
  • the top piece and/or at least one fixing means and/or at least one positioning means consist at least partially of a biocompatible material.
  • the top piece and/or at least one fixing means and/or at least one positioning means consist at least partially of a resorbable or non-resorbable polymer (e.g. polylactide (PLA), polycaprolactone (PCL), bioresorbable alloys (e.g. based on magnesium)).
  • a resorbable or non-resorbable polymer e.g. polylactide (PLA), polycaprolactone (PCL), bioresorbable alloys (e.g. based on magnesium)).
  • the top piece and/or a positioning means have a wall thickness of at least 0.1 mm, preferably 0.2-0.3 mm in particular in the case of titanium, and 0.5-1 mm in particular in the case of polycaprolactones, however at least as much so that a dimensional stability of the top piece or respectively of a positioning means results.
  • the top piece and/or at least one positioning means has a constant or a varying wall thickness.
  • At least one fixing means is a pin, a screw, a nail and/or a bone adhesive.
  • the fixing means is or respectively are preferably arranged in the region of the bone defect site.
  • the top piece has at least one milling (bore for the fixing means).
  • the filling corresponds to the fixing means.
  • the wall facing the bone defect has a surface conditioning.
  • the surface can have a microstructuring, pores, osteoblast attractants, means for promoting bone growth and/or bone substitute means containing BMP.
  • the top piece has at least one opening. This means that the top piece does not have to have a closed wall. Through a plurality of openings, the top piece can have, at least in places.
  • a network structure wherein the side of the top piece of the network structure facing away from the bone defect or the side of the top piece of the network structure facing the bone defect corresponds to the shape of the regenerated bone.
  • the top piece has at least one fastening device (e.g. a recess) for at least one implant which is to be set.
  • fastening device e.g. a recess
  • At least one fastening device e.g. a recess
  • at least one fastening device is covered at least partially by a portion of the top piece which is connected to the remaining portion of the top piece by means of at least one predetermined breaking point.
  • At least one positioning means is arranged on the top piece, which positioning means has a side facing away from the healthy bone and a side facing the healthy bone and at least partially corresponding thereto.
  • At least one predetermined breaking point is arranged between the top piece and at least one positioning means.
  • the covering device is produced in accordance with the method for producing a covering device for a bone defect site according to one of claims 1 to 14 .
  • At least one fixing means position adapted specifically to the use of at least one fixing means, which position enables a fixing of the top piece within the bone defect site or on the healthy bone, is predetermined, wherein at least one fixing means in its fixing means position, adapted specifically to the use of this fixing means, which enables a fixing of the top piece within the bone defect site or on the healthy bone, is detachably connected to the top piece so that for fixing the top piece within the bone defect site or on the healthy bone by means of this fixing means, detachably connected to the top piece, the connection between the fixing means and the top piece is detached, whereby the top piece by means of this fixing means is able to be fixed within the bone defect site or on the healthy bone.
  • the fixing means is detachably connected to the top piece by means of at least one predetermined breaking point, so that the detaching of the connection between the fixing means and the top piece takes place by breaking of the at least one predetermined breaking point.
  • the top piece is immediately able to be fixed by means of this fixing means, or after the detaching of the fixing means from the top piece, the fixing means is removed from the fixing means position, in order to carry out at least one method step before a fixing of the top piece, possible thereby, by means of this fixing means which is brought into the fixing means position again.
  • At least one positioning means is arranged on the top piece, wherein at least one positioning means is used in order to bring the covering device into the insertion position.
  • at least one positioning means is removed from the top piece after the covering device has been brought into the insertion position.
  • the top piece is preferably arranged and/or fixed here exclusively in the region of the bone defect site, which is covered entirely or at least partially by the top piece, so that it does not affect the healthy bone adjoining the bone defect site, at which healthy bone, due to its health, in any case no regeneration of the bone takes place.
  • the top piece is therefore preferably adapted to the bone defect site in an accurately fitting manner and preferably terminates flush with the healthy bone.
  • the bone defect site is entirely covered by the top piece, which preferably is not projecting beyond the bone defect site.
  • a covering device as a covering device a covering device is used which was produced in accordance with the method for producing a covering device for a bone defect site according to one of claims 1 to 14 , and/or as a covering device a covering device is used which is a covering device according to one of claims 15 to 27 .
  • FIG. 1 a perspective illustration of a covering device for a bone defect site according to the invention
  • FIG. 2 another perspective illustration of the covering device for a bone defect site according to the invention, in accordance with FIG. 1 ,
  • FIG. 3 another perspective illustration of the covering device according to the invention for a bone defect site, in accordance with FIG. 1 ,
  • FIG. 4 a top view onto the covering device according to the invention for a bone defect site, in accordance with FIG. 1 , and
  • FIG. 5 a detail view of the covering device according to the invention for a bone defect site, in accordance with FIG. 1 .
  • FIG. 1 shows a perspective illustration of a covering device 1 according to the invention for a bone defect site 2 (bone defect) of a bone, in particular of a jawbone 3 .
  • the covering device 1 according to the invention which serves for the covering and/or reconstruction of a bone defect site 2 , consists of a top piece 4 , which is single-layered, and of a fixing means 5 , which is illustrated in FIG. 1 as a screw and which is able to be arranged in the bone defect site 2 , in order not to injure the healthy bone adjoining the bone defect site 2 .
  • a fixing means 5 which is illustrated in FIG. 1 as a screw and which is able to be arranged in the bone defect site 2 , in order not to injure the healthy bone adjoining the bone defect site 2 .
  • several fixing means 5 are used for fixing the top piece 4 , wherein these would preferably also be arranged in the bone defect site 2 .
  • the top piece 4 is made from a dimensionally stable, in particular rigid, material, so that it is self-supporting and no additional support is necessary.
  • the fixing means 5 is screwed through a bore 6 into the jawbone 3 .
  • a bore which is not illustrated, is produced in the jawbone 3 .
  • a pin or a pin with at least one barb is used as fixing means 5 .
  • the subsequent fixing of the top piece 4 preferably takes place by means of ultrasonic welding.
  • ultrasonic welding preferably an ultrasonic generator generates a precisely defined frequency, which is concentrated via a sonotrode.
  • the pin After the placing of the resorbable fixing means 5 (pin) onto a borehole (bore) which is pre-bored in the bone, a generated vibration provides for a liquefication of the pin surfaces at the edges thereof, whereby a sliding of the pin into the borehole is brought about.
  • the pin Through the change of the physical state, the pin also advances into the bony cavities which are unable to be reached by a conventional bone screw (screw 7 ), so that a high initial strength is achieved.
  • the pin head connects itself with the top piece 4 and, with a blocking mechanism, provides for a stable three-dimensional construct. With the ultrasonic welding, the fixing means 5 is thus softened, so that it connects with the jawbone 3 and with the top piece 4 .
  • a sealed interior 9 is produced between the jawbone 3 and the top piece 4 , which is filled through the regeneration of the bone and/or through introduction of a material or organic and/or inorganic origin, which can also be an autogenic, syngenic, allogenic, xenogenic, synthetic and/or alloplastic material, so that the regenerated bone or the introduced material corresponds to the shape of the side of the single-layered top piece 4 facing the bone defect site 2 . It would also be conceivable that the side 11 of the single-layered top piece 4 , facing away from the bone defect site 2 , corresponds to that of the shape of the bone defect site 2 .
  • the side of the top piece 4 facing the bone defect can have a surface conditioning (e.g. a microstructuring, pores, osteoblast attractants, means for promoting bone growth and/or bone substitute means containing BMP).
  • a surface conditioning e.g. a microstructuring, pores, osteoblast attractants, means for promoting bone growth and/or bone substitute means containing BMP.
  • the fixing means 5 is detachably connected to the top piece 4 by at least one connection 12 .
  • FIG. 1 shows the covering device 1 after its insertion into the bone defect site 2 , wherein the covering device 1 is not yet fixed to the bone defect site 2 by the fixing means 5 .
  • connection 12 is separated irreversibly (irrevocably) for example by pressure onto the fixing means 5 and/or a twisting of the fixing means 5 so that the fixing means can no longer be connected to the top piece 4 by means of the connection 12 .
  • the fixing means 5 is preferably connected to the top piece 4 by means of at least one connection 12 , which can be realized e.g. by at least one web, which functions as a predetermined breaking point 13 . After the detaching of the connection 12 , therefore e.g. by breaking the web or respectively the predetermined breaking point 13 , the fixing means 5 can be used as intended.
  • fixing means 5 are used, wherein at least one fixing means 5 is detachably connected to the top piece by means of at least one connection 12 , wherein the detaching of the connection 12 is irreversible, so that at least one fixing means 5 can no longer be connected to the top piece 4 by means of the connection 12 .
  • positioning means 15 which have a side facing a healthy bone 6 and a side 16 facing away from the healthy bone 6 .
  • the side facing a healthy bone at least partially touches the healthy bone 6 , whereby through the positioning means 15 a problem-free seat of the top piece 4 is guaranteed, if applicable even without arrangement of at least one fixing means 5 or at least until at least one fixing means 5 is arranged in the bone defect site 2 .
  • this has predetermined breaking points 17 , whereby after its separation it can be divided e.g. into two parts for its removal.
  • FIG. 1 shows the top piece 4 arranged at the bone defect site 2 of the partially illustrated jawbone 3 , which has teeth 18 .
  • the top piece 4 is preferably arranged only in the region of the bone defect site 2 of the jawbone 3 , so that it neither spans nor touches a healthy bone 6 .
  • the positioning means 15 arranged on the top piece 4 , have contact with the healthy bone 19 .
  • FIG. 1 a top piece 4 is illustrated, the side 10 of which, facing the bone defect, corresponds to the shape of the regenerated bone. It is also conceivable that the positioning means 15 are arranged on the top piece 4 such that the side 11 of the top piece 4 facing away from the bone defect corresponds to the shape of the regenerated bone. This could be brought about e.g. by arranging the positioning means 15 on the side 11 of the top piece 4 facing away from the bone defect.
  • the regions 19 which represent the position of the implants which are to be inserted in future, are illustrated schematically.
  • FIG. 2 shows another perspective illustration of the covering device 1 according to the invention for a bone defect site 1 , according to FIG. 1 .
  • FIG. 3 shows another perspective illustration of the covering device 1 according to the invention for a bone defect site 2 , according to FIG. 1 .
  • FIG. 4 shows a top view onto the covering device 1 according to the invention for a bone defect site 2 , according to FIG. 1 .
  • the top piece 4 has openings 20 .
  • FIG. 5 shows a detail view of the covering device 1 according to the invention for a bone defect site 2 , according to FIG. 1 .

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Transplantation (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Biomedical Technology (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
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  • Heart & Thoracic Surgery (AREA)
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  • Physics & Mathematics (AREA)
  • Geometry (AREA)
  • Manufacturing & Machinery (AREA)
  • Developmental Biology & Embryology (AREA)
  • Epidemiology (AREA)
  • Dentistry (AREA)
  • Prostheses (AREA)
US17/618,549 2019-07-04 2020-06-29 Method for Producing a Covering Device for a Bone Defect; Covering Device for a Bone Defect; Method for at Least Partially Covering a Bone Defect by Means of a Bone Defect Covering Device Brought for this Purpose to an Insertion Position Abandoned US20240033088A1 (en)

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DE102019118134.8A DE102019118134B4 (de) 2019-07-04 2019-07-04 Verfahren zur Herstellung einer Abdeckvorrichtung für eine Knochendefektstelle; Abdeckvorrichtung für eine Knochendefektstelle;
DE102019118134.8 2019-07-04
PCT/DE2020/100562 WO2021000995A1 (de) 2019-07-04 2020-06-29 Verfahren zur herstellung einer abdeckvorrichtung für eine knochendefektstelle; abdeckvorrichtung für eine knochendefektstelle; verfahren zur zumindest teilweisen abdeckung einer knochendefektstelle mittels einer hierfür in eine einsetzposition verbrachten abdeckvorrichtung für eine knochendefektstelle

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US (1) US20240033088A1 (de)
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DE102024109164A1 (de) * 2024-04-02 2025-10-02 Reoss Gmbh Aufsatz; Verfahren zur Herstellung eines Aufsatzes; Verfahren zur Auswahl eines geeigneten Aufsatzes zur zumindest teilweisen Abdeckung einer Knochendefektstelle

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WO2021000995A1 (de) 2021-01-07
EP3993731B1 (de) 2023-07-26
AU2020298662A1 (en) 2022-02-24
EP3993731A1 (de) 2022-05-11
ES2963465T3 (es) 2024-03-27
EP3993731C0 (de) 2023-07-26
DE102019118134A1 (de) 2021-01-07
DE102019118134B4 (de) 2023-11-30

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